BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 3943550 · Received April 30, 2014

    Report

    Report Number
    8020893-2014-01032
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Report Date
    February 27, 2014
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
    Product Code
    CBK
    PMA / PMN Number
    K970460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) REPLACED THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR PASSED ELECTRICAL SAFETY TEST, CALIBRATIONS, EXTENDED SELF-TESTING (EST), SHORT SELF-TESTS (SST), AND PERFORMANCE VERIFICATION TESTING (PVT). (B)(4).

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM THE USA STATED THAT DURING SERVICING OF THE DEVICE A GRAPHICAL USER INTERFACE (GUI) COMMUNICATIONS ERROR OCCURRED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DATE OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258752 840 VENTILATOR CBK COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND 840

    Patients

    Seq Age Sex Outcome Treatment
    1